The MAC External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The addition of the MAC Male Adapter does not change the indications for use for the MAC External Fixation System.

Device Description

The purpose of this submission is to add a Male Adapter Assembly to the previously cleared MAC External Fixation System. The subject MAC Male Adapter Assembly is intended to attach to the existing MAC Module), and allows the MAC to connect to other external fixation components, including: Construx Female Telescoping Arm, Carbon T-clamp, the DFS Angular Hinge and the Carbon Ankle component. These connections allow the surgeon to treat a variety of bone conditions amenable to treatment by use of the external fixation modality.

AI/ML Overview

The provided text describes a 510(k) summary for the "MAC External Fixation System," specifically regarding the addition of a "Male Adapter Assembly." The acceptance criteria and supporting evidence are related to the mechanical performance of this new component.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Static construct testing met pre-established acceptance criteria established by predicate devices.	The assembled constructs (MAC Male Adapter + aluminum components, and carbon components) met the pre-established acceptance criteria established by the predicate devices.
Fatigue construct testing to one million cycles met pre-established acceptance criteria established by predicate devices.	The assembled constructs (MAC Male Adapter + aluminum components, and carbon components) met the pre-established acceptance criteria established by the predicate devices.

Study Details

The study described is a mechanical testing study to demonstrate substantial equivalence, not a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested fields are not applicable (N/A) in this context.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of constructs tested, but it refers to "assemblies" of the MAC Male Adapter with aluminum and carbon components.
- Data Provenance: N/A (Mechanical testing, not human data). The testing was conducted internally or by a testing facility as part of the regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth here refers to engineering specifications and performance benchmarks derived from predicate devices, not expert human interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Mechanical testing results are objective measurements against defined criteria, not subjective interpretations requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is a mechanical device, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a hardware device; there is no algorithm involved.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for performance was established by "pre-established acceptance criteria established by the predicate devices." This implies engineering specifications and performance benchmarks derived from similar, already approved external fixation systems.
The sample size for the training set: N/A. This refers to mechanical testing, not a machine learning model.
How the ground truth for the training set was established: N/A. No training set is applicable here. The "ground truth" for the mechanical tests was based on performance criteria derived from predicate devices.

Summary

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102843

Image /page/0/Picture/1 description: The image shows the logo for Biomet Trauma. The word "BIOMET" is in a bold, sans-serif font, with the letters connected. Below the word "BIOMET" is the word "TRAUMA" in a smaller, sans-serif font.

MAY - 3 2011

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date:	April 4, 2011
Applicant/Sponsor:	Biomet Trauma100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Margaret F. CrowePhone: 973-299-9300 x2260Fax: 973-257-0232
Trade name:	MAC External Fixation System
Common Name:	External fixation system
Classification Name(Product Code):	KTT/Single/multiple component metallic bonefixation appliances and accessories
Device Panel - RegulationNumber:	Orthopedic - 21 CFR 888.3030

Device Description:

Indications for Use:

Summary of Technologies:

The MAC Male Adapter is similar in terms of material and design features to previously cleared components of the MAC External Fixation System. These components include the

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MAC Female Diaphyseal Adapter (previously cleared in premarket notification K021695). This device is intended to connect the MAC Module to other external fixation components. This component is made of similar materials to the MAC Male Adapter, and is assembled in a similar way to the MAC Module.

Substantial Equivalence:

The additional MAC male adapter is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness. Examples of predicates include the MAC External Fixation System found substantially equivalent in K021695 and K030372. The MAC System was also found substantially equivalent for use in a pediatric population in K081244. Based upon the mechanical testing, the new component of the MAC External Fixation System is substantially equivalent for its intended use to other external fixation systems currently on the market. The testing provided included:

. Static construct testing of the MAC Male Adapter assembled to aluminum components, and carbon components. The assembled constructs met the preestablished acceptance criteria established by the predicate devices.
� Fatigue construct testing of the MAC Male Adapter assembled to aluminum components, and carbon components to one million cycles. The assembled constructs met the pre-established acceptance criteria established by the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY - 3 2011

Biomet Trauma % Ms. Margaret Crowe Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K102843

Trade/Device Name: MAC External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTI Dated: April 25, 2011 Received: April 26, 2011

Dear Ms. Crowe:

We have,reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (FMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Margaret Crowe

CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 08 the Center for 1)cvices and Radiological Health's (CDRH's) Office of Compliance. 3022. Inchile ase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFF) Prod. 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Pari 803), please go to

http://www.lda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Ilivision of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

My B. Rh
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 102843

Device Name: MAC External Fixation System

Indications for Use:

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Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Asr. M. Melkerm

(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, Division ODSurgious, and Restorative Devices

510(k) Number K102843

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.